The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries, or veins. The Identi Loops is not designed nor indicated for implantation.

Device Description

The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction,, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loops is not designed nor indicated for implantation. The Identi Loops are manufactured using the same manufacturing processes as our previous 510(k). Both this 510(k) and our previous 510(k) are from silicone rubber. The Degania Silicone Identi Loops have similar technical and performance characteristics to the Substantially Equivalent Identi Loops. Both Identi Loops are available in Mini. Maxi and Super Maxi. The Identi Loops and the Identi Loops to which they are Substantially Equivalent are sterilized by the same process.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Degania Silicone Identi Loops:

The provided documents are a 510(k) Summary and an FDA-issued clearance letter for the Degania Silicone Identi Loops. These documents primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting specific performance data from a clinical or technical study in the format typically used for AI/ML device evaluations.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from these documents. The "study" in this context is the submission for 510(k) clearance based on substantial equivalence to a predicate device, not a performance study as would be conducted for a novel device or AI/ML product.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Intended Use: Temporary intraoperative use for identification, retraction, or occlusion of tendons, ureters, nerves, arteries, or veins. Not for implantation.	Substantial Equivalence: The device is "designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loops is not designed nor indicated for implantation." This exactly matches the predicate device.
Manufacturing Process: Must be consistent and safe.	Substantial Equivalence: "The Identi Loops are manufactured using the same manufacturing processes as our previous 510(k)." Both are made from silicone rubber.
Technical & Performance Characteristics: Must be similar to the predicate.	Substantial Equivalence: "The Degania Silicone Identi Loops have similar technical and performance characteristics to the Substantially Equivalent Identi Loops. Both Identi Loops are available in Mini, Maxi and Super Maxi." The document explicitly states "We are substantially equivalent to ourselves," referring to a previously cleared device from the same manufacturer. This implies that the technical specifications (e.g., material properties, dimensions) are either identical or within acceptable variation to the predicate.
Sterilization Method: Must be effective and safe.	Substantial Equivalence: "The Identi Loops and the Identi Loops to which they are Substantially Equivalent are sterilized by the same process." This implies compliance with a validated sterilization method suitable for the device material and intended use.
Classification: Regulatory classification (Class II).	Regulatory Clearance: FDA confirmed the regulatory class as II and cleared the device based on substantial equivalence.
General Controls Compliance: Adherence to FDA requirements (e.g., GMP, labeling).	FDA Clearance: The FDA letter states that marketing is "subject to the general controls provisions of the Act," including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. This implies an expectation of compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The submission is based on substantial equivalence, not a clinical "test set" with performance data in the typical sense. It relies on the existing safety and effectiveness of the legally marketed predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. No such "ground truth" establishment process for a test set is described, as the submission focuses on comparing the new device's characteristics to a predicate, not evaluating its performance against a new dataset. The "experts" involved would be the regulatory affairs personnel and potentially internal engineers at Degania Silicone, as well as the FDA reviewers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. No adjudication method is described for a test set. The determination of substantial equivalence is made by the FDA based on the information provided in the 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/ML device, and no MRMC study was performed or is relevant to this type of medical device clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not provided in the context of device performance. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (which in this unique case, is an earlier version of the same manufacturer's device). The argument is that the new device is sufficiently similar to the predicate that it raises no new concerns about safety or effectiveness.

8. The sample size for the training set

Not applicable / Not provided. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable / Not provided. As there is no training set, this question is not relevant.

In summary: The provided documents represent a 510(k) substantial equivalence submission, which operates on the principle that if a new device is sufficiently similar to a legally marketed predicate device (in terms of intended use, technological characteristics, and safety/effectiveness profile), it does not require a new premarket approval. Therefore, the "study" is the comparison against the predicate, and the "acceptance criteria" are compliance with FDA's substantial equivalence requirements, rather than performance metrics from a traditional clinical study.

Summary

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a 1998 JUL

Image /page/0/Picture/1 description: The image shows the words "Degania Silicone" in a split-screen format. The word "Degania" is written in white letters on a black background. The word "Silicone" is written in black letters on a white background.

The Standards Institution of Israel

ISO
9002

Quality Assured Firm

Degania Silicone Ltd.

Degania Bet 15130, Isracl. Tel: 972-6-6755712, Fax: 972-6-6709182

R981956

APPENDIX E 510(K) Summary

Trade Name: Degania Silicone Identi Loops Common Name: Vascular Ties or Loops Product Code: DXC/GCZ Device Class: II Classification Panel: General and Plastic Surgery Establishment Registration Number: 8030107

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Device Description and Use:

Manufacturing:

The Identi Loops are manufactured using the same manufacturing processes as our previous 510(k). Both this 510(k) and our previous 510(k) are from silicone rubber.

Technical Characteristics:

The Degania Silicone Identi Loops have similar technical and performance characteristics to the Substantially Equivalent Identi Loops. Both Identi Loops are available in Mini. Maxi and Super Maxi.

Sterilization:

The Identi Loops and the Identi Loops to which they are Substantially Equivalent are sterilized by the same process.

Substantial Equivalence: We are substantially equivalent to ourselves.

Bett

Bette Lubin Product Advisor & Regulatory Affairs Degania Silicone Ltd.

Date 2 June 1998

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

a 1008 JUL

Ms. Bette Lubin Product Advisor & Regulatory Affairs Degania Silicone, Ltd. Degania Bet 15130, Israel

Re: K981956 Trade Name: Degania Silicone Identi Loops Regulatory Class: II Product Code: DXC Dated: June 2, 1998 Received: June 4, 1998

Dear Ms. Lubin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Ms. Bette Lubin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/1 description: The image shows a seal or logo with the text "The Standards Institution of Israel" arranged in a semi-circular fashion at the top and "Quality Assured Firm" at the bottom, also in a semi-circular arrangement. In the center of the seal, the text "ISO 9002" is prominently displayed. The seal appears to be a mark of quality assurance or certification from The Standards Institution of Israel, indicating compliance with ISO 9002 standards.

Degania Silicone Ltd. Degania Bet 15130, Isracl. Tel: 972-6-6755712, Fax: 972-6-6709182

INDICATIONS FOR USE

Device Name: Degania Silicone Identi Loops

Indications for Use: The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries, or veins. The Identi Loops is not designed nor indicated for implantation.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: [X]
or
Over- the -Counter: [ ]
(Per 21 CFR 801.109

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K981956
(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).